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RSS FeedPosted by Michael Wonder on 13 Oct 2016
Agenda for 19 October Transparency Commission meeting
12 October 2016 - HAS has published the agenda for the next scheduled Transparency Commission meeting. ...
Posted by Michael Wonder on 27 Sep 2016
Idelvion now registered in Australia
27 September 2016 - CSL Behring's Idelvion is now approved by the TGA. ...
Posted by Michael Wonder on 19 Sep 2016
Agenda for 21 September 2016 TC meeting
19 September 2016 - The Transparency Commission will consider the reimbursement of a number of new medicines and blood products. ...
Posted by Michael Wonder on 15 Sep 2016
TGA approves new indication for Alprolix
15 September 2016 - The TGA has approved a new use for Biogen's Alprolix. ...
Posted by Michael Wonder on 15 Sep 2016
Shire announces U.S. FDA approval of Cuvitru [immune globulin (human), 20% solution for subcutaneous injection] treatment for primary immunodeficiency
14 September 2016 - Approval follows positive data from clinical studies on efficacy and tolerability, as well as infusion time and ...
Posted by Michael Wonder on 01 Aug 2016
Shire announces FDA approval of Adynovate with Baxject III reconstitution system
1 August 2016 - New system reduces number of steps in the treatment process for haemophilia A patients on Adynovate [antihemophilic ...
Posted by Michael Wonder on 31 Jul 2016
ADMA Biologics receives complete response letter from FDA for pending biologics license application
29 Jul 2016 - ADMA Biologics announced that the U.S. FDA has issued a complete response letter to the company’s biologics ...
Posted by Michael Wonder on 16 Jul 2016
Agenda for the 20 July 2016 TC meeting
15 July 2016 - The Transparency Commission will consider the reimbursement of new medicines and blood products. ...
Posted by Michael Wonder on 30 Jun 2016
Agenda for the 6 July 2016 TC meeting
30 June 2016 - The Transparency Commission will consider the reimbursement of new medicines and blood products. ...
Posted by Michael Wonder on 17 Jun 2016
TGA publishes AusPAR for simoctocog alfa rhu (Nuwiq)
17 June 2016 - The TGA has published an AusPAR for Octapharma's Nuwiq (simoctocog alfa). ...
Posted by Michael Wonder on 16 Jun 2016
Shire and Kamada announce FDA approval of expanded label for self-infusion of Glassia for the treatment of emphysema due to severe AAT deficiency
15 June 2016 - Glassia is the only FDA approved alfa-1 antitrypsin (human) augmentation treatment that patients can self-infuse at home. ...
Posted by Michael Wonder on 02 Jun 2016
Agenda for the 8 June 2016 TC meeting
1 June 2016 - The Transparency Commission will consider the (continued) reimbursement of dexketoprofen with tramadol hydrochloride (Skudexum), empagliflozin (Jardiance), plasma ...
Posted by Michael Wonder on 31 May 2016
EMA publishes EPAR for albutrepenonacog alfa (Idelvion)
31 May 2016 - The EMA has published an EPAR for albutrepenonacog alfa (Idelvion). ...
Posted by Michael Wonder on 26 May 2016
FDA approval of Afstyla (rFVIII-single chain)
26 May 2016 - CSL today announced that the US FDA has approved Afstyla [anti-haemophilic factor (recombinant), single chain], CSL Behring’s ...
Posted by Michael Wonder on 25 May 2016
EMA publishes EPAR for eftrenonacog alfa (Alprolix)
25 May 2016 - The EMA has published an EPAR for eftrenonacog alfa (Alprolix). ...